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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: TAK-935 Clear all
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935

NCT02497235
View directory record Official record
Conditions
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
Interventions
TAK-935, [18F]MNI-792 (tracer)
Drug
Lead sponsor
Takeda
Industry
Eligibility
19 Years to 55 Years
Enrollment
11 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Apr 10, 2017 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies

NCT03166215
View directory record Official record
Conditions
Developmental and/or Epileptic Encephalopathies
Interventions
TAK-935, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
11
States / cities
Phoenix, Arizona • Port Charlotte, Florida • Tampa, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jan 6, 2021 · Synced Sep 4, 2026, 4:09 PM EDT
Terminated Phase 2 Interventional Results available

A Study of Soticlestat in Adults and Children With Rare Epilepsies

NCT03635073
View directory record Official record
Conditions
Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
Interventions
Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years and older
Enrollment
156 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
27
States / cities
Phoenix, Arizona • Los Angeles, California • Aurora, Colorado + 18 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study of Soticlestat Tablets in Healthy Adults

NCT05284760
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 55 Years
Enrollment
96 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Feb 27, 2024 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 3 Interventional Results available

A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome

NCT04938427
View directory record Official record
Conditions
Lennox Gastaut Syndrome (LGS)
Interventions
Placebo, Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 55 Years
Enrollment
270 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
24
States / cities
Phoenix, Arizona • Tucson, Arizona • Los Angeles, California + 17 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2024 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935

NCT02201056
View directory record Official record
Conditions
Healthy Volunteers
Interventions
TAK-935, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
19 Years to 55 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2015
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Jul 11, 2016 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies

NCT03650452
View directory record Official record
Conditions
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
Interventions
TAK-935, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 17 Years
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
15
States / cities
Phoenix, Arizona • Los Angeles, California • Aurora, Colorado + 12 more
Source: ClinicalTrials.gov public record
Updated Feb 17, 2021 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience

NCT05602818
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Soticlestat 300 mg, Soticlestat 600 mg, Soticlestat 900 mg, Alprazolam, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 55 Years
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Dec 8, 2024 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults

NCT05064449
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Soticlestat, Itraconazole, Mefenamic acid
Drug
Lead sponsor
Takeda
Industry
Eligibility
19 Years to 55 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Oct 2, 2023 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 2 Interventional Results available

A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)

NCT03694275
View directory record Official record
Conditions
15q Duplication Syndrome, CDKL5 Deficiency Disease
Interventions
Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
8
States / cities
Los Angeles, California • Aurora, Colorado • Norcross, Georgia + 3 more
Source: ClinicalTrials.gov public record
Updated May 25, 2022 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 3 Interventional Results available

A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

NCT04940624
View directory record Official record
Conditions
Dravet Syndrome (DS)
Interventions
Soticlestat, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 21 Years
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
10
States / cities
Phoenix, Arizona • Los Angeles, California • San Francisco, California + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

TAK-935 Multiple Rising Dose Study in Healthy Participants

NCT02539134
View directory record Official record
Conditions
Epilepsy
Interventions
TAK-935, Placebo
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 55 Years
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2016
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Jul 11, 2017 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function

NCT05098054
View directory record Official record
Conditions
Hepatic Impairment, Healthy Volunteers
Interventions
Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 75 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
5
States / cities
Edgewater, Florida • Miami, Florida • Orlando, Florida + 2 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2024 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants

NCT04992442
View directory record Official record
Conditions
Healthy Volunteers
Interventions
TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution
Drug
Lead sponsor
Takeda
Industry
Eligibility
19 Years to 55 Years · Male only
Enrollment
6 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Oct 3, 2021 · Synced Sep 4, 2026, 4:09 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants

NCT02906813
View directory record Official record
Conditions
Healthy Volunteers
Interventions
TAK-935 Tablets, TAK-935 Oral Solution
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 55 Years
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Sep 18, 2018 · Synced Sep 4, 2026, 4:09 PM EDT
Terminated Phase 3 Interventional Results available

A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome

NCT05163314
View directory record Official record
Conditions
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
Interventions
Soticlestat
Drug
Lead sponsor
Takeda
Industry
Eligibility
2 Years to 56 Years
Enrollment
352 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
26
States / cities
Phoenix, Arizona • Tucson, Arizona • Los Angeles, California + 19 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Sep 4, 2026, 4:09 PM EDT